Glossary

A - B - C - D - E - G - H - I - J - M - N - O - P - R - S - T - U - W

A

Adequate Control - The concept of “adequate control” is based on the assumption that there is a “safe threshold” below which adverse effects do not occur, and that regulators together with industry can determine acceptable levels of exposure from these risk calculations. This approach has lead to widespread contamination to low levels of many chemicals. Unfortunately, the effects of chronic exposure to a chemical are difficult to predict accurately. Furthermore adverse effects may occur due to exposure to multiple chemicals. Additionally, the levels of some persistent contaminants can build up over time to levels of concern, which then cannot be remedied.

Androgens - Chemicals responsible for the development and maintenance of the male sexual characteristics. They are structurally similar to estrogens; indeed, estrogens are produced in the body from androgenic precursors. Testosterone, produced mainly by the testes, is the principal human androgen.

Annex XIV - List of substances subjected to the ’authorisation’ procedure in REACH. The use and marketing of all ’substances of very high concern’ will require an explicit authorisation. In some cases this may mean an obligation to replace them with safer alternatives.

Authorisation Dossier - Dossier prepared by a company to support a specific use of a substance that requires authorisation. Amongst other information, it contains an analysis of alternatives.

B

Bio-accumulative Chemicals - A substance is bio-accumulative if it is stored in the body, often in fatty tissue. Even low concentrations in the environment can lead to high concentrations in the body as the amount stored in the body builds up over time. These substances accumulate further as they move up the food chain, which means that if plants show even low levels of harmful substances, higher concentrations are already detectable in herbivores, such as cows, increasing further in carnivores through to humans, who are at the top of the food chain. A toxin that has been transported along the food chain through different stages will have a very high accumulation factor.

C

C&L - Classification and Labelling - a Directive of the European Union. Official Name: Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (as amended).

Candidate list - A list of all substances of very high concern, whose properties make them eligible to go through the REACH Authorisation procedure. The first version due to be published in Autumn 2009, with priorities to be established for which substances will be first be processed through authorisation.

CAS - Chemical Abstract Service

Cefic - European Chemical Industry Council

CMR chemicals - an abbreviation for chemicals that are Carcinogenic – those that cause cancer, Mutagenic – those that change DNA, and Reprotoxic, meaning they are harmful to human reproduction and can cause miscarriages and birth defects.

Comitology – Refers to the committee system which oversees the acts implemented by the European Commission. The committees are made up of representatives from EU Member States and are chaired by the Commission. They ensure that the Commission is able to establish a dialogue with national administrations before implementing measures.

The Commission - Short for the European Commission.

Competent Authorities - these are the national government bodies/ministries responsible for enforcement of REACH within each EU Member State.

CRAP – Community Rolling Action Plan - Lists which substances have been targeted for the substance evaluation process.

CSTEE - EU Scientific Committee on Toxicology, Ecotoxicology and Environment

CSA - Chemical Safety Assessment. This is a risk assessment, carried out by the producer of a substance, known as a ‘Chemical Safety Assessment’, (CSA) which is documented in the Chemical Safety Report. This is required for substances produced or imported in quantities over 10 tonnes per year.

CSR - Chemical Safety Report. CSR are documents that detail the hazards associated with a particular chemical and provide industry with a tool for demonstrating that it can use chemicals safely. Downstream users may require their manufacturers or importers to address their use in the CSR (called an identified use). Alternatively, they may decide to preserve the confidentiality of their use from their manufacturer or importer, and - in case their use is not covered in the exposure scenario annexed to the SDS – prepared their own CSR. See also CSA.

D

DNEL - Derived No-Effect Level

Dossier - a registration dossier. In REACH, Registration requires manufacturers and importers to provide specific information on their substances and to use that data to manage them safely. There is a general obligation for manufacturers and importers of substances to submit a “registration dossier” to the Agency.

DU - Downstream Users - As defined in REACH, any natural or legal person established within the Community, other than manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.

E

ECB - European Chemicals Bureau

ECHA - Also the Agency, or the European Chemicals Agency, based in Helsinki, Finland. ECHA will manage the technical, scientific and administrative aspects of the REACH system at Community level, aiming to ensure that REACH functions well and has credibility with all.

ECVAM - European Centre for the Validation of Alternative Methods under the EU Joint Research Centre.

EINECS - List of chemicals compiled in 1981 that today are considered "existing substances".

ELINCS - European List of Notified Chemical Substances

EMEA - European Medicines Agency

EDCs - Endocrine Disrupting Chemicals. These are chemicals have the ability to mimic or hormones or interfere with the hormonal systems of people and wildlife, in particular with the thyroid hormones and sex hormones. The endocrine system is made up of the glands such as the pituitary and the thyroid which make hormones. In lay terms these chemicals are known as hormone disrupters.

Endocrine disrupters - "An endocrine disrupter is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations"

Endocrine System - A complex network of glands, hormones and receptors. It provides the key communication and control link between the nervous system and bodily functions such as reproduction, immunity, metabolism and behaviour.

ESIS - European Chemical Substance Information System

EU - European Union - A supranational and intergovernmental union of 27 Member States. Ministers from the Member States make up the “Council of Ministers”.

EC - The European Commission - The main lawmaking and executive body of the European Union; it consists of 27 Commissioners from each of the Member States and is supported by an administrative body, divided into departments called “Directorate-General”.

EP - The European Parliament - The parliamentary body of the European Union with Members from each Member State who are directly elected by the citizens. Together with the Council, the Parliament forms the legislative branch of the EU.

The Court of Justice of the European Communities - Usually called the European Court of Justice, is the highest court of the European Union. It is based in Luxembourg City, unlike most of the rest of the European Union institutions, which are based in Brussels and Strasbourg.

EUSES - European Union System for the Evaluation of Substances

Evaluation - As required by REACH, this has two parts. A dossier evaluation involves checking the completeness of the registration dossier. A substance evaluation, conducted by the European Chemicals Agency and Member State authorities, of the registered (and other) information determines the hazards and risks of a particular substance.

G

GHS - The UN’s Globally Harmonised System of Classification and Labelling

GLP - Good Laboratory Practice

H

Health and Safety Data - ‘Health’ refers to the toxicological and ecotoxicological data that tell us about how a substance behaves in the environment and in living organisms – the ways in which it may be poisonous. ‘Safety’ refers to the physical/chemical properties of a substance, such as whether it is explosive, corrosive, its boiling point, evaporation point, etc.

HPV - High Production Volume Chemicals. In REACH defined as those over 1000 tonnes per year.

I

IARC - International Agency for Research on Cancer

ICCA - International Council of Chemical Associations

IFCS - Intergovernmental Forum on Chemical Safety

ILO - International Labour Organisation

Incidence - Incidence is the number of new cases of a condition, symptom, death, or injury that arise during a specific period of time, such as in a year. It is often expressed as a percentage of a population (for example, 25% of Americans were diagnosed with the flu in 2002).

In vitro-testing - Studies done with cell or tissue cultures

In vivo - testing - Studies done with live animals

IUCLID - International Uniform Chemical Information Database

IUPAC - International Union for Pure Applied Chemistry

J

JRC - Joint Research Centre of the European Union

L

LCA - Life Cycle Assessment

LOEL - Lowest observed Effect Level

LVP - Low Production Volume Chemicals, usually taken to mean those below 10 tonnes per annum

M

MOS - Margins of safety

MS CAs - Member States Competent Authorities

N

NGOs - Non-governmental organisations - technically it can mean an organisation that is not a government. This could include industry trade associations which represent commercial interests. In common usage, it means groups such as health, environmental, women’s and consumer groups, which represent the public interest.

NLP - No-Longer Polymers

NOAEL - No observed adverse effect level

NOEC - No observed effect concentration

NOEL - No observed effect level

O

Oestrogens - a group of chemicals of similar structure mainly responsible for female sexual development and reproduction. They are produced mainly by the ovaries but also by the adrenal glands and adipose (fat) tissue. The principal human oestrogen is 17beta-oestradiol.

OSPAR - Commission for the Protection of the Marine Environment of the Northeast Atlantic: http://www.ospar.org. The Contracting Parties to the Oslo and Paris Conventions are Belgium, Denmark, the European Union, Finland, France, Germany, Iceland, Ireland, the Netherlands, Norway, Portugal, Spain, Sweden, and the UK. In July 1998 (Sintra Statement) OSPAR identified a List of Chemicals for Priority Action, which were targeted for the “cessation of discharges, emissions and losses … by the year 2020”.

ORATS - Online European Risk Assessment Tracking System

OSOR - One Substance, One Registration - a proposal which arose during the development of the REACH legislation.

P

PBT - Persistent, Bioaccumulative and Toxic substances - Persistent - degrade slowly or do not breakdown at all, Bio-accumulative – accumulate in human bodies and the environment.

PEC - Predicted environmental concentration

Persistent chemicals - Certain chemicals only break down chemically or biologically very slowly in the environment. In other words, they persist in the environment. Over time, their concentration in the environment increases.

Phase-in substances – As defined in REACH, chemicals produced or marketed before 1981.

PIC - Prior Informed Consent - The Rotterdam Convention of Prior Informed Consent sets up a system to control international trade in certain hazardous substances.

PNEC - Predicted No-Effect Concentration

Polymers - Large molecules consisting of repeated chemical units (monomers)

POPs - Persistent Organic Pollutants

PPORD - Product and Process Oriented Research and Development

vPvB - very Persistent and very Bioaccumulative (see PBT above)

Precautionary Principle - The obligation to take preventive action when a chemical is suspected of causing harm to human health and/or the environment in the absence of conclusive scientific evidence in order to ensure a high level of environmental protection and of human, animal and plant health.

R

REACH - Abbreviation for the new EU Chemicals legislation – “Registration, Evaluation, Authorisation and restriction of CHemicals”.

RA - Risk Assessment

RAR - Risk Assessment Report

Registration - As required by REACH: registration of basic health and safety information of substances produced in or imported to the EU over 1 tonne per year per producer or importer, to be submitted by companies.

Restriction - As required by REACH: restriction of the uses of chemicals with properties of concern at Community level.

RIPs - REACH Implementation Projects - RIP documents are published at the following website: http://ecb.jrc.it/reach/rip/

RMM - Risk Management Measures

S

SAICM - Strategic Approach to International Chemicals Management

SDS - Safety Data Sheet - Tool for information transfer for all dangerous substances

Safe Threshold - A level below which adverse effects do not occur, also see “Adequate Control” above.

SAR (Q) - SAR (Quantitative) Structure Activity Relationship

SEA - Socio-economic Analysis

SIDS - Screening Information Data Set

SIEF - Substance Information Exchange Forum

SPORT - Strategic Partnership on REACH Testing

Substitution Principle - The Principle of Substitution states that hazardous chemicals should be systematically replaced with safer available alternatives. These alternatives could be chemical, material or functional (technological

SVHC - Stands for “Substances of Very High Concern”, which are required to be authorized under REACH. These are substances which fall into one of these classifications/categories:

• Carcinogens (cause cancer), mutagens (cause gene mutations), or toxic to reproduction (CMR category 1 and 2), • Persistent (degrade slowly or do not break down at all), Bio-accumulative (accumulate in human bodies and the environment) and Toxic (PBT), • Very Persistent and very Bio-accumulative (vPvB), or • Identified from scientific evidence as causing probable serious effects to humans or the environment equivalent to those above on a case by case basis, for instance substances that interfere with the hormone system.

T

Third (interested) parties - These include any private or public organisation (e.g. individuals, public authorities, NGOs, international organisations and non EU countries). Third parties do not have obligations under REACH but they may provide information on substances to the Agency.

Toxic Chemicals - A substance is seen as toxic if it represents a threat to human health. While some toxic substances can be quickly broken down again in the environment or in the body, those that are toxic, persistent and bioaccumulative, are of very high concern.

TGD - Technical Guidance Document

tpa - Tonnes per annum

TSCA - Toxic Substance Control Act

U

UNCED - United Nations Conference on Environment and Development

UNEP - United Nations Environment Programme

UNICE - Union des Industries de la Communauté Européenne. Federation of European industries

UVCB - Substances of unknown variable composition, complex reaction products or biological materials

W

WTO - World Trade Organisation